Senior Specialist, External Manufacturing

MSD; Visakhapatnam; Híbrido; INR 2.500.000 - 4.500.000; Jornada completa

Descripción de la vacante

MSD is seeking a Technical Leader in External Manufacturing for Small Molecule Drug Substance. You will lead the interface with external partners, drive tech transfers, scale-up, validation, and process optimization across the network of external manufacturers.

You will guide process development, ensure regulatory and quality compliance, and manage complex investigations while supporting site readiness and continuous improvement. Hybrid work arrangement in India with ~50% travel.

Formación

• Bachelor’s degree in engineering, chemistry sciences or related discipline with 7+ years of relevant pharma manufacturing experience.
• Experience leading drug substance transfers, new product introductions, and technical transfers.
• Strong problem-solving, risk assessment, and root cause analysis skills.

Responsabilidades

• Lead interface on technical issues between technical operations and external partner.
• Provide technical leadership for NPI, scale-up, validation, and manufacturing of drug substance.
• Guide process development, scale-up, and robustness with shop-floor support.
• Assess technology viability and ensure adherence to standards with external partners.
• Collaborate with external manufacturing, QA, regulatory to monitor partner performance and drive improvements.
• Conduct due diligence on external partners and support tech transfers and site readiness.
• Drive validation strategies for new and existing products and resolve manufacturing issues.
• Support process improvements and capacity optimization with external partners.
• Lead investigations and manage changes with interface to multiple sites.

Conocimientos

Accountability

Adaptability

Biopharmaceutical Manufacturing

Business

Contract Manufacturing

External Manufacturing

Lean Six Sigma

Leadership

Process Optimization

Regulatory Awareness

Educación

Bachelor’s degree in engineering, chemistry sciences or related discipline

Descripción del empleo

Job Description

Job Description

External Manufacturing Small Molecule Drug Substance Technical Lead, CTO

Our Small Molecule API Technical Operations Unit is seeking a highly motivated individual to fill an open Technical Leader positions, to support drug substance manufacture within our External Manufacturing Network. This is an exciting opportunity to work with key strategic external partners, contribute and enhance technical experience in small molecule drug substance manufacturing, and work on high visibility network initiatives. Our team strives to provide technical excellence in our work and be strong partners, collaborators, and leaders within the small molecule line of business at our company.

Our team of chemists and engineers help ensure that external manufacturing operations remain operational, continuously improve and innovate.

Primary responsibilities for this position include, but are not limited to, the following:

• Lead and act as the primary interface on technical issues between technical operations and the external partner.
• Provide technical leadership within the technical operations group for the new product introduction, scale up, validation and manufacture of drug substance.
• Knowledge of standard small molecule API unit operations, including optimisation, trouble shooting and ability to proactively identify and mitigate risks for the associated equipment
• Provides technical guidance to the external partner, assesses viability of technology in proposed process configurations, verifies adherence to required standards, and ensures deliverables are technically sound.
• Collaborates with external manufacturing operations, external quality, regulatory, and others to evaluate external partner(s) performance, fostering pro-active risk management mindset and continuous improvement
• Executes technical due diligence assessments at external partner(s).
• Ensures tech transfers are positioned for successful business outcomes. Executes technical transfers and receiving site readiness activities.
• Executes validation strategies for new and existing products.
• Provides manufacturing process support to external partner(s) to resolve production issues and to provide guidance on process and capacity optimization.
• Supports/coordinates/manages complex investigations, with appropriate interface with other impacted manufacturing sites.
• Provides technical review, oversight and direct input to external partner process change requests, deviations, and master batch record changes. Minimizes duplication of efforts between external partner and our systems.
• Drives and supports continuous process verification and process performance monitoring program for all products under his/her responsibility.
• Understands the true regulatory requirements and partners with operations, quality, and the external partner to develop more efficient ways to meet these requirements.

Education and Minimum Requirements:

• Bachelor’s degree in engineering, chemistry sciences or related discipline with a minimum of 7 years of relevant work experience in manufacturing, in the areas of process start up, routine manufacturing and/or technical transfer.

Required Skills and Experience:

• Minimum of 5 of experience in drug substance with experience in leading Drug Substance new product introduction, technical transfers, commercial manufacturing.
• Demonstrated knowledge and experience in process development, scale up and process robustness, including shop floor (person in plant) support.
• Strong problem-solving skills, root cause analysis and risk assessment/mitigation.
• Ability to work effectively across boundaries to build strong collaborative relation with internal and external teams, to drive alignment and results.
• A high level of effectiveness in professional and interpersonal communication skills, including stakeholder management, are required.
• Authentic and inclusive people leadership, able to provide examples of your ability to engage and create a psychologically safe and collaborative culture.
• Must be able to work under own initiative, priorities appropriately based on business need and work within tight deadlines.
• Flexibility and the ability to work independently as well as excellent organizational skills.
• Strong knowledge of quality systems, drug substance manufacturing and validation.
• Excellent command of English (both written and oral).
• Travel will be a requirement of this position at approximately 50%.

Preferred Experience and Skills:

• Project management experience.
• Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.

Additional location(s) Compensation Information:

Required Skills:

• Accountability
• Accountability
• Adaptability
• Biopharmaceutical Manufacturing
• Business
• Clinical Supply Chain Management
• Communication
• Contract Management
• Contract Manufacturing
• Driving Continuous Improvement
• Establishing Contacts
• External Manufacturing
• Healthcare Innovation
• Interpersonal Communication
• Lean Manufacturing
• Lean Six Sigma (LSS)
• Lean Six Sigma Continuous Improvement
• Management Process
• Manufacturing
• Manufacturing Operations
• Manufacturing Support
• Process Optimization
• Production Process Development
• Production Scheduling
• Project Human Resource Management {+ 7 more}

Employee Status:

Regular

Flexible Work Arrangements:

Hybrid

Job Posting End Date:

11/2/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.